Summary
This study focuses on individuals with previously untreated metastatic or unresectable melanoma (melanoma that has spread or cannot be removed with surgery). A combination of 2 drugs, nivolumab and relatlimab, will be given to participants. Intravenous (IV) formulation of this combination is approved by the U.S. Food and Drug Administration (FDA) based on studies showing it is well-tolerated and led to improvement in progression-free survival. In this study, researchers will evaluate whether subcutaneous (under the skin) administration is possible without leading to additional toxicity and any reduction in benefits.
Inclusion Criteria
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
- Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
- Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
Study Location(s)
Cedars-Sinai Cancer at The Angeles Clinic and Research Institute
More about this Clinical Trial
Full Title
CA224127: A Phase 3, open-label study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants with Previously Untreated Metastatic or Unresectable Melanoma